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HARMONY BIOSCIENCES TO PRESENT NEW WAKIX® (PITOLISANT) SAFETY AND EFFICACY DATA AT SLEEP 2023 ANNUAL MEETING
Late-breaking Phase 2 proof-of-concept study in Prader-Willi syndrome accepted for poster presentation PLYMOUTH MEETING, Pa., May 10, 2023 /PRNewswire/ --
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"Late-breaking Phase 2 proof-of-concept study in Prader-Willi syndrome accepted for poster presentation\nPLYMOUTH MEETING, Pa., May 10, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (\"Harmony\") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that new safety and efficacy data from a Phase 2 proof-of-concept study evaluating pitolisant for the treatment of excessive daytime sleepiness in patients with Prader-Willi syndrome (PWS) will be highlighted as a poster presentation during a late-breaking abstract session at the 37th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as \"SLEEP 2023,\" in Indianapolis from June 3-7. \n\n \n \n \n \n \n \n\n \nAdditional presentations by Harmony include an oral presentation covering a pooled analysis of clinically meaningful improvements in adults with narcolepsy, as well as poster presentations detailing the results of a pharmacokinetics study of WAKIX in breast milk and serum in healthy lactating women, and an ongoing prospective observational safety study evaluating WAKIX exposure in pregnant women and their offspring.\n\"As a company dedicated to developing and delivering treatments for rare neurological disorders, we are pleased to share a broad range of data for pitolisant at this year's SLEEP meeting,\" said Harmony's Chief Medical Officer, Kumar Budur M.D., M.S. \"These data add to the growing body of scientific evidence that has been generated for pitolisant to help further characterize its safety, tolerability and clinical utility.\"\nDr. Budur added that the company is especially encouraged by the positive results from the Phase 2 proof-of-concept study in PWS in anticipation of an upcoming Phase 3 registration trial.\n\"Together, the data presented at SLEEP 2023 demonstrate Harmony's commitment to expanding the clinical utility of pitolisant for adult patients with narcolepsy while rigorously pursuing new indications for treating patients with unmet medical needs in other rare neurological disorders.\"\nThe following data presented by Harmony will be available in the meeting's gallery:\nOral and Poster: \"Clinically Meaningful Improvements with Pitolisant in Adults with Narcolepsy: Pooled Analysis of Randomized Clinical Trials...